Ovarian Follicle Function in Patients With Primary Ovarian Failure

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ClinicalTrials.gov Identifier:

NCT00001275

First Posted: November 4, 1999

Last Update Posted: October 6, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous premature ovarian failure. We know that one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This is a diagnostic omnibus protocol that permits baseline clinical evaluation of patients with prematurem ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols.

Further study details as provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):

Enrollment:

1134

Study Start Date:

May 12, 1991

Estimated Study Completion Date:

February 8, 2017

Detailed Description:

No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous primary ovarian insufficiency. We know that more than one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This protocol permitted baseline clinical evaluation of patients with primary ovarian insufficiency and ongoing observation of the natural history of the disorder. The protocol is now in the follow up and analysis phase and is not now recruiting new patients. Now a major aim of the protocol is to investigate large scale medical sequencing as a method by which to uncover mechanisms of primary ovarian insufficiency and to assist in the management of women with this condition. This will involve a community-based participatory research approach.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 42 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

INCLUSION CRITERIA:

Women 18 to 42 years of age with primary ovarian insufficiency who meet the following requirements were candidates for recruitment to the study: 1) at least a four month history of oligo-amenorrhea not due to pregnancy, and 2) clearly elevated gonadotropins in the menopausal range on two separate occasions at least one month apart.

EXCLUSION CRITERIA:

Women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency were not candidates.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001275

Locations

United States, Maryland

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Lawrence M Nelson, M.D.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)